Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
Overview
This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.
Full Title of Study: “Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: March 30, 2020
Detailed Description
Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.
Interventions
- Drug: Dexamethasone injection
- Group A consisted of patients given 5 mg intravenous dexamethasone after induction.
- Drug: Haloperidol Injection
- Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended
Arms, Groups and Cohorts
- Active Comparator: Dexamethasone
- 5 mg intravenous dexamethasone
- Active Comparator: Haloperidol
- 1 mg intravenous haloperidol
Clinical Trial Outcome Measures
Primary Measures
- Nausea and Vomiting
- Time Frame: Within 24 hours postoperative
- Number of patients experiencing nausea and vomiting postoperative
Secondary Measures
- Pain and VAS
- Time Frame: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
- Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome
Participating in This Clinical Trial
Inclusion Criteria
- underwent laparoscopic surgery (gynecology, digestive, or urology surgery) – American Society of Anesthesiologist (ASA) physical status 1-3 Exclusion Criteria:
- psychological or neurological disorders (routine haloperidol consumption) – history of allergic reaction to dexamethasone or haloperidol – diabetes mellitus – did not give the consent
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Indonesia University
- Provider of Information About this Clinical Study
- Principal Investigator: Aldy Heriwardito, Principal Investigator – Indonesia University
- Overall Official(s)
- Aldy Heriwardito, Doctor, Principal Investigator, Indonesia University
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